Stress - Prevention of Sleep Disorders, PTSD and Depression Clinical Trial
— RESTOfficial title:
Efficacy of an Online Cognitive Behavioral Therapy (CBT) Programme Aiming at Reducing the Stress of Health Workers Involved in the Care of Patients During the Covid-19 Epidemic: a Randomized-controlled Trial
| NCT number | NCT04362358 |
| Other study ID # | 7799 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 20, 2020 |
| Est. completion date | September 1, 2021 |
| Verified date | August 2023 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Some preliminary epidemiological research conduct in China in health workers involved in the care of Covid-19 patients has shown high rates of depression (>50%), generalized anxiety disorder (>44%), insomnia (>36%) and stress symptoms (>73%), which negatively impact their well-being as well as their ability to work effectively . These rates were observed during the epidemic peak, but they can also have a long-term mental health effect, both individually, but also in a systemic manner , similar to what has been reported relative to the SARS-CoV-1 . Cognitive behavioral therapy (CBT) is recognized as an effective treatment for stress-reduction, as well as for the prevention of multiple mental health problems in at-risk individuals . Moreover, CBT has been found to be effective in brief online formats , which could make it feasible during the current Covid-19 epidemic. To our knowledge, there are no online CBT programmes targeting stress problems in health workers involved in the care of patients during the current epidemic context. The aim of our study is to evaluate the efficacy of the online CBT programme we have developped to specifically address immediate perceived stress in health workers, as well as the prevention of mental health problems at 3- and 6-months follow-up
| Status | Completed |
| Enrollment | 156 |
| Est. completion date | September 1, 2021 |
| Est. primary completion date | September 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Health worker - Male or Female - Aged 18-70 - Able to understand the French language Exclusion Criteria: - PSS < 16 - Suicidal ideation assessed as < 3 on the item 9 of the PHQ-9 - legally able to provide informed consent |
| Country | Name | City | State |
|---|---|---|---|
| France | Weiner Luisa | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Significant score reduction at the Perceived Stress Scale | T0 inclusion | ||
| Primary | Significant score reduction at the Perceived Stress Scale | T1 (3-month follow-up) | ||
| Primary | Significant score reduction at the Perceived Stress Scale | T1 (up to 8 weeks treatment) | ||
| Primary | Significant score reduction at the Perceived Stress Scale | T2 (6-month follow-up) |